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Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico (PROSPECT)

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ClinicalTrials.gov Identifier: NCT03794531
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
FDI Clinical Research of Puerto Rico
University of Massachusetts, Lowell
University of Puerto Rico Medical Sciences Campus
Information provided by (Responsible Party):
Josiemer Mattei, Harvard School of Public Health

Brief Summary:
The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a multi-frame sampling of probabilistic plus community approaches, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

Condition or disease
Heart Diseases Type2 Diabetes Hypertension Obesity Dyslipidemias Metabolic Syndrome Cardiovascular Diseases Chronic Disease Inflammation Psychological Stress Physiological Stress Depressive Symptoms Coping Behavior Diet Habit Lifestyle

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of participants with self-reported medically-diagnosed chronic diseases [ Time Frame: 4 years ]
    Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors)


Secondary Outcome Measures :
  1. Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area [ Time Frame: 4 years ]
    Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area


Other Outcome Measures:
  1. Risk of clinically-measured metabolic syndrome (e.g. high blood pressure, elevated adiposity, elevated blood glucose, and out-of-normal-range blood lipids), according to dietary and psychosocial risk factors [ Time Frame: 4 years ]
    Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors


Biospecimen Retention:   Samples Without DNA
Blood, urine, saliva, hair.


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Representative sample of eligible adults living in all of Puerto Rico.
Criteria

Inclusion Criteria:

  1. Age 30-75 years old at the time of enrollment
  2. Non-institutionalized
  3. Living in PR at the time of the first interview and the year before and not planning to move from the island within 3 years
  4. Able to answer questions without assistance

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794531


Locations
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Puerto Rico
FDI Clinical Research
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Harvard School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
FDI Clinical Research of Puerto Rico
University of Massachusetts, Lowell
University of Puerto Rico Medical Sciences Campus

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Responsible Party: Josiemer Mattei, Assistant Professor of Nutrition, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03794531     History of Changes
Other Study ID Numbers: 143792
R01HL143792 ( U.S. NIH Grant/Contract )
R21MD013650 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control on the study website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 2-years
Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Josiemer Mattei, Harvard School of Public Health:
Cardiovascular disease
Chronic disease risk factors
Hispanics/Latinos
Minority health
Puerto Rico
Cardiometabolic health
Disaster research
Caribbean and Latin America
Population health
Prospective study
Allostatic load

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Chronic Disease
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Disease Attributes
Inflammation
Metabolic Syndrome
Dyslipidemias
Depression
Stress, Psychological
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Behavioral Symptoms